Hip osteoarthritis Musculoskeletal Diseases Coxarthrosis [arthrosis of hip]
Conditions
Interventions
All patients will receive the type of implant to which they have been randomly allocated and thus two groups of patients will be created: group A: Tri-Lock Bone Preservation Stem group and group B: Mi
Sponsors
University of Patras Research Committee (ELKE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Planned total hip replacement for osteoarthritis 2. Unilateral osteoarthritis 3. Patients aged 50-80 4. Diagnosis: primary osteoarthritis, inflammatory arthritis, avascular necrosis, and post-traumatic arthritis 5. Patient willing and able to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Severe comorbidities affecting the functional outcome (i.e. symptomatic lumbar pathology) 2. Activity-limiting pain in either knee or contralateral hip 3. Patients with poor bone stock or any femoral deformity precluding fit and fill in the metaphysis, such as cases of hip dysplasia and severe valgus or metaphyseal deformity secondary to fracture 4. Planned bilateral procedures within the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The incidence of all hip-related complications up to 2 years after surgery. Hip-related complications are defined as intra- and postoperative fractures, dislocation, wound infection, early or late loosening and revision surgery of any implant for any reason 2. Patient-reported outcome measures, assessed with WOMAC and SF-36 scores at baseline, 3 months, 6 months, 1 year and 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hip function evaluated with Harris hip score (HHS) at baseline, 3 months, 6 months, 1 year and 2 years 2. Pain measured using the Numeric Pain Rating Scale (NPRS) at baseline, 3 months, 6 months, 1 year and 2 years 3. Patient satisfaction with the outcome at 1 and 2 years, categorized as: overall satisfaction, satisfaction with pain relief, functional improvement to perform daily activities and satisfaction with ability to perform recreational activities. Patients will be classified as very satisfied, somewhat satisfied, somewhat dissatisfied and dissatisfied 4. Functional assessment by motion analysis using an inertial measurement unit (IMU: Free4Act59, 60, Lor An Engineering, Bologna, Italy), based on three different physical performance tests: 1) gait along a 12-m walkway at the patient’s self-selected normal speed, 2) 12-m gait in high speed in respect to patient’s functional status and 3) up and go test, at 1 and 2 years. The Free4Act sensor is positioned at the dorsal side of the pelvis, centrally between both posterior superior iliac spines. Spatiotemporal gait parameters will be recorded, including: walking speed (m/s), cadence (steps/min) and affected leg step time (s), step length (m), step time irregularity (%), stance and swing phase duration (% of gait cycle) 5. Femoral prosthesis fitting, alignment and stability assessed with detailed radiographic analysis at 3 months, 6 months, 1 year and 2 years | — |
Countries
Greece
Outcome results
None listed